The following data is part of a premarket notification filed by Coors Biomedical Co. with the FDA for Osteograf/ar+(plus) Alveolar Rid Hydrox 18-40 Mesh.
| Device ID | K861083 |
| 510k Number | K861083 |
| Device Name: | OSTEOGRAF/AR+(PLUS) ALVEOLAR RID HYDROX 18-40 MESH |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | COORS BIOMEDICAL CO. 12860 WEST CEDAR DR. SUITE 210 Lakewood, CO 80228 |
| Contact | Mary L Armstrong |
| Correspondent | Mary L Armstrong COORS BIOMEDICAL CO. 12860 WEST CEDAR DR. SUITE 210 Lakewood, CO 80228 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-21 |
| Decision Date | 1986-04-30 |